Lead SARS-CoV-2 Candidate Vaccines: Expectations from Phase III Trials and Recommendations Post-Vaccine Approval

Viruses. 2020 Dec 31;13(1):54. doi: 10.3390/v13010054.

Abstract

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is transmitted primarily through respiratory droplets/aerosols and it causes COVID-19. The virus infects epithelial cells by using the spike protein on its surface to bind to angiotensin-converting enzyme 2 receptor on the cells. Thus, candidate vaccines targeting the spike protein are currently being developed to prevent against infections. Approximately 44 SARS-CoV-2 candidate vaccines are in clinical trials (phase I-III) and an additional 164 candidates are in preclinical stages. The efficacy data from phase I/II trials of lead candidate vaccines look very promising with virus-neutralizing geometric mean antibody titers in the range of 16.6-3906. Most recently, two SARS-CoV-2 candidate vaccines, BNT162b2 and mRNA-1273, have been granted the first emergency use authorization (EUA) in the U.S.; BNT162b2 has also been granted an EUA in the United Kingdom, Canada, and in the European Union. This review assesses whether SARS-CoV-2 candidate vaccines (with approved EUA or in phase III trials) meet the criteria for an ideal SARS-CoV-2 vaccine. The review concludes with expectations from phase III trials and recommendations for phase IV studies (post-vaccine approval).

Keywords: COVID-19; SARS-CoV-2; SARS-CoV-2 vaccines; clinical trials.

Publication types

  • Research Support, Non-U.S. Gov't
  • Review

MeSH terms

  • 2019-nCoV Vaccine mRNA-1273
  • Antibodies, Neutralizing / immunology
  • BNT162 Vaccine
  • COVID-19 / prevention & control*
  • COVID-19 Vaccines*
  • Canada
  • Clinical Trials as Topic
  • Clinical Trials, Phase III as Topic
  • Clinical Trials, Phase IV as Topic
  • Drug Approval*
  • Europe
  • Humans
  • SARS-CoV-2*
  • Spike Glycoprotein, Coronavirus / immunology
  • United Kingdom
  • United States
  • Vaccines, Synthetic
  • mRNA Vaccines

Substances

  • Antibodies, Neutralizing
  • COVID-19 Vaccines
  • Spike Glycoprotein, Coronavirus
  • Vaccines, Synthetic
  • spike protein, SARS-CoV-2
  • 2019-nCoV Vaccine mRNA-1273
  • BNT162 Vaccine